An interventional study of Metanx and Placebo in Diabetes and Peripheral Neuropathy, sponsored by St. Luke's Hospital and Health Network, Pennsylvania. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-17.
Sponsored by St. Luke's Hospital and Health Network, Pennsylvania · Not applicable, Interventional, and Treatment
This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →St. Luke's Hospital and Health Network, Pennsylvania is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The control group will receive placebo pill twice daily for twelve months.
Drug: Placebo
Metanx group will receive one pill twice daily for twelve months.
Dietary Supplement: Metanx
Metanx- one tablet twice daily for twelve months
Placebo- one tablet twice daily for twelve months.
Increased intraepidermal nerve fiber density
If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density
Time frame: 1 year
Subjective improvement
Improvement in the subjective score versus the placebo group.
Time frame: 1 year
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
St. Luke's Hospital and Health Network, Pennsylvania